KR20080099213A - Injection rubber stopper for biomedical and production method - Google Patents
Injection rubber stopper for biomedical and production method Download PDFInfo
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- KR20080099213A KR20080099213A KR1020080093041A KR20080093041A KR20080099213A KR 20080099213 A KR20080099213 A KR 20080099213A KR 1020080093041 A KR1020080093041 A KR 1020080093041A KR 20080093041 A KR20080093041 A KR 20080093041A KR 20080099213 A KR20080099213 A KR 20080099213A
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- rubber
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- polyolefin
- rubber stopper
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/10—Homopolymers or copolymers of propene
- C08L23/12—Polypropene
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/17—Component parts, details or accessories; Auxiliary operations
- B29C45/18—Feeding the material into the injection moulding apparatus, i.e. feeding the non-plastified material into the injection unit
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- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
- C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
- C08L23/16—Elastomeric ethene-propene or ethene-propene-diene copolymers, e.g. EPR and EPDM rubbers
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Chemistry (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Manufacturing & Machinery (AREA)
- Mechanical Engineering (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Description
본 발명은 의료용 사출 고무전 및 이의 제조방법에 관한 것으로서, 더욱 상세하게는 폴리올레핀(폴리프로필렌) 및 엘라스토머의 재료(Ethylene Propylene Rubber)를 선정하여 수액 용기를 밀봉하는 동시에 수액 세트를 연결시 파편 생성을 방지하고 획기적 제조공정 단축으로 가격이 저렴하며 기능성 및 약물접촉 안정성을 확보하는 고무전 및 이를 사출방식으로 제조한 제조방법을 제공한다. The present invention relates to a medical injection rubber sheet and a method for manufacturing the same, and more specifically, polyolefin (polypropylene) and the material of the elastomer (Ethylene Propylene Rubber) by selecting the sealing fluid container at the same time to create the debris when connecting the fluid set It provides a rubber sheet and a manufacturing method manufactured by injection method to prevent the cost and shorten the breakthrough manufacturing process and secure the functionality and drug contact stability.
수액용 고무마개(스토퍼; Stopper)인 고무전을 제조하기 위한 종래의 생산공정(PRESS 공정)은 복잡하고 시간상으로도 매우 불리한 조건들을 가지고 있다. 원료를 칭량하고 배합하며 이를 소련 및 숙련과정을 거친다. 이 때 가공된 고무를 숙성시키고 다시 혼련해서 재단, 성형 및 가공하여 최종 제품이 나오는 일련의 과정동안 소요되는 시간이 많다. 상기와 같은 생산과정에서 비롯되는 과다한 공수 투입으로 높은 원가 구성이 불가피하며 생산시간 과다소요로 인한 생산성 향상의 장애 요인이 발생한다. The conventional production process (PRESS process) for producing rubber fields, which are rubber stoppers (stoppers) for fluids, is complicated and has very disadvantageous conditions in time. The raw materials are weighed and blended and go through the Soviet Union and skilled processes. At this time, the processed rubber is aged, kneaded again, cut, molded and processed to take a long time during a series of processes in which the final product is produced. Due to the excessive air input from the production process as described above, high cost composition is inevitable, and excessive production time causes obstacles to productivity improvement.
기존 고무전의 경우 수액용 스토퍼로 사용시 세트나 주사바늘(Needle)의 수 차례 사용에 의한 파편발생 및 탄성 회복력이 저하되는 문제점을 야기하고, 또한 고무 자체의 경시적인 노화현상이 발생되는 단점과 함께 생산 공정 중 가류방법에 의한 제조로 규격편차가 과다 발생한다. 또한 품질 조건을 만족하는 범위 내에서의 소재선택의 한계(Butyl)가 있으며 기존 고무전의 경우 원재료에서 비롯되는 각종 오염물질, 특히 알루미늄에 대한 약액내 용출이 심각하게 대두될 것으로 보이며 이에 따라 알루미늄(Al) 용출의 법적 규제 움직임으로 소재 사용 한계에 직면하였다.In case of existing rubber field, it causes the problem of debris generation and elastic recovery ability by using several sets or needles when used as a stopper for fluid, and also produces the aging phenomenon of rubber itself over time. Excessive standard deviation occurs due to vulcanization during the process. In addition, there is a limit of material selection within the range that satisfies the quality conditions, and in the case of existing rubber fields, elution in chemical liquids for various contaminants, especially aluminum, originating from raw materials is expected to emerge seriously. As a result of the legal regulation of leaching, material usage limitations were encountered.
본 발명은 위와 같은 점을 고려하여 수액 용기를 밀봉하는 동시에 수액세트(SET)를 연결시 파편생성을 방지하고 획기적 제조 공정 단축으로 가격이 저렴하며 폴리올레핀 소재사용으로 약물의 접촉안정성을 확보하는 사출방식으로 제조한 고무전 및 이의 제조방법을 제공한다.In view of the above, the present invention seals the infusion container and at the same time prevents the generation of debris when connecting the infusion set (SET), the cost is low by the breakthrough manufacturing process, and the injection method of securing the contact stability of the drug by using polyolefin material It provides a rubber field and a method for producing the same.
본 발명은 폴리올레핀 5∼10 중량% 및 엘리스토머 90∼95 중량%로 이루어져 있으며 경도 35∼40인 것이고 본 발명의 의료용 사출 고무전에 있어서 폴리올레핀은 폴리프로필렌이고 엘리스토머는 에틸렌프로필렌러버((Ethylene Propylene Rubber)이며 본 발명의 의료용 사출 고무전 수액용기에 연결하여 사용되는 것이다.The present invention is composed of 5 to 10% by weight of polyolefin and 90 to 95% by weight of elastomer and has a hardness of 35 to 40. In the medical injection rubber of the present invention, the polyolefin is polypropylene and the elastomer is ethylene propylene rubber ((Ethylene Propylene Rubber) ) Is used in connection with the medical injection rubber fluid infusion container of the present invention.
본 발명은 기존 의료용, 특히 수액용 고무마개 등에서 용출될 수 있는 알루미늄의 사용 규제에 따른 선택적 소재 적용 문제에서 알루미늄이 최소한으로 함유 한 원료(Resin)을 제공하며 기존 고무전의 획기적 제조 공정 단축으로 인한 생산성 향상 및 원가 경쟁력 확보가 가능하며 고무의 탄성과 플라스틱의 물성을 동시에 가지므로 기존 고무전의 단점이던 스토퍼로 사용시 I.V. 세트(SET) 및 니들(Needle)에 의한 파편생성을 방지하고 사출 고무전에 I.V. 세트 삽입후 회복력 보강으로 삽입시 발생되는 함몰현상을 예방하는 기능적으로 우수한 수액용 고무전을 제공하여 의료산업상 매우 유용한 것이다.The present invention provides a raw material (Resin) containing a minimum of aluminum in the problem of applying selective materials according to the regulation of the use of aluminum that can be eluted from the conventional medical, especially sap rubber stopper, and productivity due to the shortened manufacturing process of conventional rubber fields It can be improved and secured cost competitiveness, and it has elasticity of rubber and physical property of plastic at the same time. Prevents debris generation by SET and Needle and I.V. It is very useful in the medical industry by providing a functionally excellent infusion rubber warp that prevents the phenomena that occur during insertion by reinforcing resilience after inserting a set.
본 발명은 폴리올레핀 5∼10 중량% 및 엘리스토머 90∼95 중량%로 이루어져 있으며 경도 35∼40인 것을 특징으로 하는 의료용 사출 고무전에 관한 것이다. 본 발명의 의료용 사출 고무전에 있어서 폴리올레핀은 폴리프로필렌이고 엘리스토머는 에틸렌프로필렌러버((Ethylene Propylene Rubber)인 것을 특징으로 한다. 또한 본 발명의 의료용 사출 고무전 수액용기에 연결하여 사용되는 것을 특징으로 한다.The present invention relates to a medical injection rubber field comprising 5 to 10% by weight of polyolefin and 90 to 95% by weight of elastomer and having a hardness of 35 to 40. In the medical injection rubber of the present invention, the polyolefin is polypropylene, and the elastomer is ethylene propylene rubber (Ethylene Propylene Rubber), characterized in that it is used in connection with the medical injection rubber fluid container of the present invention. .
본 발명에서 폴리올레핀 5 중량%이하 경우 사용시 제품이 너무 단단하여 사용상 매우 불편하며 폴리올레핀 10 중량%이상 경우 제품의 경도가 소프트한 문제가 생겨 제품의 사용시 문제가 될 수 있다. 본 발명의 의료용 사출 고무전은 의료용으로 사용이 적합한 PO계(폴리프로필렌; PP) 및 엘라스토머(Elastomer)의 선정으로 기능성 및 약물 안정성의 품질조건을 만족하는 독립된 TPE(Thermoplastic Elastomer)로 제조하여 고무의 탄성과 플라스틱의 물성을 동시에 가지므로 수액(Intra Venous) 세트 삽입후 고무전의 복원력을 향상시키고 파편발생을 방지하며 이물발생문제를 차단한다. 또한 본 발명의 의료용 사출 고무전은 생산 공정에서 가공이 용이하여 수액용 스토퍼(Stopper)로 이용시 사출성형으로 쉽게 생산 가능하며 생산공정의 단축으로 효율적이며 염가의 고무전을 제공한다. In the present invention, when the polyolefin is less than 5% by weight, the product is too hard to be used, which is very inconvenient to use, and when the polyolefin is more than 10% by weight, the hardness of the product may be soft, which may be a problem when the product is used. The medical injection rubber field of the present invention is made of an independent TPE (Thermoplastic Elastomer) that satisfies the quality conditions of functionality and drug stability by selecting PO-based (polypropylene; PP) and elastomer (Elastomer) suitable for medical use. It has the properties of elasticity and plastic at the same time, improves the restoring force of rubber field after inserting Intra Venous set, prevents the occurrence of debris and blocks foreign matters. In addition, the medical injection rubber field of the present invention is easy to process in the production process can be easily produced by injection molding when used as a stopper (stopper) for the sap, provides an efficient and inexpensive rubber field by shortening the production process.
본 발명의 의료용 사출 고무전에서 고무전의 파편은 고무전 파편시험법( British Standard 3263)을 이용하여 테스트하였고 방법은 고무전 샘플 20개에 대하여 21 게이트(GAGE)의 니들(Needle)을 사용하여 직경 5㎜ 내에서 5회 수직삽입하여, 생성 파편수가 "3개 이하"이면 적합이나 보다 현저히 좋은 결과가 발생하고 기존 고무전인 부틸러버 대비 탁월한 품질의 결과를 도출한다. 본 발명의 의료용 사출 고무전에서 약물 안정성 시험의 경우 부틸고무전과 TPE로 사출된 고무전을 비교 실험결과 더 안정적인 것으로 나타났다. 실험방법은 약액은 생리식염(Normal Saline)주를 100mL 유리병(Glass Bottle) 50mL 충전하고 시편은 용출을 용이하게 하기 위하여 4등분하여 용기에 투입하고 “1회 멸균, 2회 멸균, 3회 멸균”연속 실시로 가혹조건 설정하여 6개월(Initial, 1개월, 3개월, 6개월), 40℃ 드라이오븐(Dry Oven)의 조건에서 실시한다. 실험 결과는 가혹조건(3회 반복 멸균)에서 용출을 하여도 안정한 수준이며 자외선(UV)의 경우 기존 부틸고무가 상대적으로 불안정하게 평가된 반면에 사출용 고무전의 경우 안정적으로 평가된다.In the medical injection rubber field of the present invention, the rubber field fragments were tested using the rubber field fragment test method (British Standard 3263), and the method was performed using a needle of 21 gates (GAGE) for 20 rubber field samples. By inserting five times within 5 mm, the number of generated fragments is "three or less", which results in a suitable but more remarkable result and results in superior quality compared to butyl rubber, which is conventional rubber. The drug stability test in the medical injection rubber field of the present invention was found to be more stable as a result of comparison experiments of the rubber field injected with butyl rubber field and TPE. In the test method, the chemical solution was filled with 50 mL of 100 mL glass bottle, and the specimens were divided into 4 parts to facilitate elution. ”Severe conditions are set for continuous operation, and it will be carried out under conditions of 6 months (Initial, 1 month, 3 months, 6 months) and 40 ℃ dry oven. The test results are stable even in the severe conditions (3 times sterilization), and in the case of UV light, the existing butyl rubber is evaluated relatively unstable, whereas in the case of injection rubber fields it is evaluated stably.
기존의 프레스(Press)형 공정은 배합, 가류 메타(Meter), 성형, 커팅(Cutting), 세척 및 약물처리, 이화학 시험, 최종검사, 포장의 단계를 거친다. 사출 공정의 경우 보압 공정, 냉각/용융/계량 공정, 형개/취출 공정, 최종검사, 포장의 단계로 생산 공정이 단축되는 동시에 모든 공정이 사출기에서 이루어지므로 의료용 자재의 중요한 요건인 이물 혼입이 방지된다.Conventional press-type processes go through the steps of compounding, vulcanization meta, molding, cutting, cleaning and drug treatment, physicochemical testing, final inspection and packaging. In the case of the injection process, the production process is shortened to the pressure holding process, cooling / melting / measuring process, mold opening / extraction process, final inspection, and packaging, and all the processes are performed at the injection machine, thereby preventing foreign material mixing, an important requirement for medical materials. .
도 1은 종래 고무전 제조방법을 나타낸 개략도.1 is a schematic view showing a conventional rubber field manufacturing method.
도 2는 본 발명에 따른 고무전 제조방법의 실시예를 나타낸 공정도이다. 2 is a process chart showing an embodiment of a rubber field manufacturing method according to the present invention.
<도면의 주요 부분에 대한 부호의 설명><Explanation of symbols for the main parts of the drawings>
10 : 기존 고무전의 원료 공급공정 11 : 사출용 고무전의 원료 공급공정10: raw material supply process of existing rubber field 11: raw material supply process of rubber field for injection
20 : 기존 고무전의 배합 공정 30 : 기존 고무전의 성형 공정20: Mixing process of existing rubber field 30: Molding process of existing rubber field
40 : 기존 고무전의 성형 공정 41 : 사출용 고무전의 성형 공정 40: molding process of existing rubber field 41: molding process of rubber field for injection
50 : 기존 고무전의 가공 공정 60 : 기존 고무전의 검사 및 포장공정 50: processing process of existing rubber field 60: inspection and packaging process of existing rubber field
61 : 사출용 고무전의 검사 및 포장 공정61: Inspection and Packaging Process of Injection Rubber Sheet
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| DE60025482T2 (en) * | 1999-05-28 | 2006-09-28 | Novo Nordisk A/S | SPRAYED STOPPER FOR DRUG CONTAINERS |
| JP2000353432A (en) | 1999-06-11 | 2000-12-19 | Sumitomo Wiring Syst Ltd | Corrugated tube for electric wire protection |
| JP2003038638A (en) | 2001-05-23 | 2003-02-12 | Sekisui Chem Co Ltd | Tube for transfusion bag |
| JP2004215860A (en) | 2003-01-14 | 2004-08-05 | Sytecs Corp | Joint plug for vial |
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